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NCT Number: NCT02441478

Co-operative Behavior and Decision-making in Frontal Lobe Epilepsy

Epilepsy is a frequent neurological disorder with about a third of patients having seizures despite treatment. At least some of these seizures can be linked to a low compliance and therapy adherence of patients. Compliance is defined as "the extent to which a person's behavior (in terms of taking medication, following diets, or executing life style changes) coincides with medical or health advice". Therapy adherence of patients suffering from epilepsy is low with reported rates between 30 and 50%, although adherence to anticonvulsive drug therapy is critical for effective disease management and low therapy adherence is associated to higher mortality in epilepsy. The reasons for low therapy adherence are still a matter of research. Some known factors influencing compliance in epilepsy are related to its chronic nature, but others seem to lie in a complex interaction between psychiatric comorbidity and an impairment of neural systems underlying behavior. Furthermore, therapy adherence rests a variable difficult to measure, especially in epileptic patients where classical tools such as questionnaires and electronic monitoring devices have been shown to be imprecise. It has been argued that the term 'compliance' should be replaced by 'co-operative behavior' and non-compliance can therefore be interpreted as troubled co-operative behavior. This behavioral approach offers the potential of using tools and methods of the latest developments in behavioral neuroscience. Neuroeconomics, a scientific field on the border of psychology, economics and neuroscience, has used economic game paradigms in order to operationalize cooperative behavior and to identify several brain areas by functional brain imaging that have been linked to social co-operative behavior. The majority of these brain areas are located in the frontal cortex [ventromedial frontal/orbitofrontal cortex, and rostral anterior cingulate cortex. Epilepsies originating in the frontal lobe are subsumed under the term "frontal lobe epilepsy" (FLE) and represent 20-30% of all partial seizures and 25% of all refractory focal epilepsies referred to epilepsy surgery.

The investigator's project plans to study compliance and cooperative behavior of patients suffering from frontal lobe epilepsies through a neuroeconomic approach by (1) comparing the behavior of these patients in the prisoners' dilemma game to the behavior of age-, gender-, and education-matched healthy controls, (2) correlation of game behavior to brain activation measured by functional magnetic resonance imaging in both patients and healthy controls and (3) studying the link between cooperative behavior to compliance captured by pill counts and questionnaires.

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Key information

Conditions

Frontal Lobe Epilepsies Behavior Brain Diseases Central Nervous System Diseases Cooperative Behavior Epilepsies, Partial Epilepsy Epilepsy, Frontal Lobe Epileptic Syndromes Nervous System Diseases Social Behavior

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospices Civils de Lyon

Lyon, 69002, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

(Patients):

  • Age between 18 and 50
  • Diagnosis of frontal lobe epilepsy
  • Written consent to participate
  • Right-handed
  • Hospital Anxiety and Depression Scale Score under 10
  • Obsessive Compulsive Inventory Score under 40
  • Sufficient language skills
  • Social insurance

Inclusion criteria

(controls):

  • Age between 18 and 50
  • Written consent to participate
  • Right-handed
  • Hospital Anxiety and Depression Scale Score under 10
  • Obsessive Compulsive Inventory Score under 40
  • Sufficient language skills
  • Social insurance

Exclusion criteria

(Patients):

  • Seizures types other than epileptic (psychogenic etc.)
  • Mental retardation
  • Epilepsies other than FLE
  • Other known neurological diseases
  • Hospital Anxiety and Depression Scale Score over 10
  • Obsessive Compulsive Inventory Score over 40
  • Pregnancy
  • non-MRI suitable transplants (cardiac pacemaker etc.), claustrophobia, orthopedic diseases that prevent lying in the scanner
  • During exclusion period of other studies
  • No social insurance

Exclusion criteria

(controls)

  • History of neurological or psychiatric diseases
  • Hospital Anxiety and Depression Scale Score over 10
  • Obsessive Compulsive Inventory Score over 40
  • Medication other than contraceptives
  • Pregnancy
  • non-MRI suitable transplants (cardiac pacemaker etc.), claustrophobia, orthopedic diseases that prevent lying in the scanner
  • Major perceptive impairments
  • During exclusion period of other studies
  • No social insurance

Treatment and study plan

functional magnetic resonance imaging exam

Radiation

Other names: fMRI exam

Primary outcomes

  1. Social cooperative behavior as measured by the prisoners' dilemma game

    Time frame: 1 day

    The prisoners' dilemma game (PDG; Trivers, 1971) is a well-studied game derived from economic game theory that has been used extensively to quantify and study cooperative behavior. The two players in the game can choose between two moves, either "co-operate" or "defect". If both players co-operate, they both receive the reward R. If one player defects, while the other one co-operates, then the defector receives the payoff T while the co-operative player receives the payoff S. If both players defect, they both receive the payoff P. (T > R > P > S).

Secondary outcomes

  1. Blood-oxygen-level dependent signal during the Prisoners' dilemma game

    Time frame: 1 day

    Whole brain analysis of correlation between behavior in the PDG (prisoners' dilemma game) and brain activation as measured by the BOLD (blood-oxygen-level dependent) signal captured through functional MRI as well as group differences between patients and controls.

  2. Neuropsychological profile

    Time frame: 1 day

    analysis of neuropsychological testing of (working) memory, attention, theory-of-mind and executive functions.

  3. Pill counts

    Time frame: 1 day

    Pills taken and not-taken during the study period will be counted as a variable of therapy adherence.

  4. Scores acquired by questionnaire

    Time frame: 1 day

    Several questionnaires to cover beliefs about therapy adherence will be applied.

  5. Scores acquired by questionnaire

    Time frame: 1 day

    questionnaire to cover beliefs about medicines will be applied

  6. Scores acquired by questionnaire

    Time frame: 1 day

    questionnaire to cover beliefs about trust towards physicians and medications will be applied

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
May 12, 2015
Registry last updated
Sep 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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